Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00003607
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.
* Compare the toxic effects of these two regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the prognostic factors of progression in these patients.
* Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).
Patients are randomized to one of two treatment arms.
* Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
* Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.
Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.
Patients are followed at 2 and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Marie Curie
🇫🇷Valance, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Oscar Lambret
🇫🇷Lille, France
Clinique de la Sauvegarde - Clinique Jeanne D'Arc
🇫🇷Lyon, France
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Institut Jean Godinot
🇫🇷Reims, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France
Centre Eugene Marquis
🇫🇷Rennes, France
Clinique de la Sauvegarde
🇫🇷Lyon, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre de Radiotherapie du Parc
🇫🇷Chalon Sur Saone, France
CHG Roanne
🇫🇷Roanne, France
Hopital d'Instruction des Armees du Val de Grace
🇫🇷Paris, France